CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.018

Catheter, Angioplasty, Peripheral, Transluminal

TRIREME MEDICAL, INC.

The following data is part of a premarket notification filed by Trireme Medical, Inc. with the FDA for Chocolate Pta Balloon Catheter (over The Wire) 0.014 Guide Wire, Chocolate Pta Balloon Catheter (over The Wire) 0.018.

Pre-market Notification Details

• Device ID: K130414
• 510k Number: K130414
• Device Name: CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.018
• Classification: Catheter, Angioplasty, Peripheral, Transluminal
• Applicant: TRIREME MEDICAL, INC. 7060 Koll Center Parkway Suite 300 Pleasanton, CA 94566
• Contact: Shiva Ardakani
• Correspondent: Shiva Ardakani; TRIREME MEDICAL, INC. 7060 Koll Center Parkway Suite 300 Pleasanton, CA 94566
• Product Code: LIT
• CFR Regulation Number: 870.1250 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-02-19
• Decision Date: 2013-06-15
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00763000430412	K130414	000
00763000336639	K130414	000
00763000336646	K130414	000
00763000336653	K130414	000
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00763000336677	K130414	000
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00763000336691	K130414	000
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00763000336714	K130414	000
00763000336721	K130414	000
00763000336738	K130414	000
00763000336745	K130414	000
00763000336752	K130414	000
00763000336769	K130414	000
00763000336776	K130414	000
00763000336783	K130414	000
00763000336622	K130414	000
00763000430580	K130414	000
00763000430429	K130414	000
00763000430436	K130414	000
00763000430443	K130414	000
00763000430450	K130414	000
00763000430467	K130414	000
00763000430474	K130414	000
00763000430481	K130414	000
00763000430498	K130414	000
00763000430504	K130414	000
00763000430511	K130414	000
00763000430528	K130414	000
00763000430535	K130414	000
00763000430542	K130414	000
00763000430559	K130414	000
00763000430566	K130414	000
00763000430573	K130414	000
00763000336790	K130414	000
00763000240295	K130414	000
00763000115111	K130414	000
00763000115128	K130414	000
00763000115135	K130414	000
00763000115142	K130414	000
00763000115159	K130414	000
00763000115166	K130414	000
00763000115173	K130414	000
00763000115180	K130414	000
00763000115197	K130414	000
00763000115203	K130414	000
00763000115210	K130414	000
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00763000240332	K130414	000
00763000240349	K130414	000
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00763000240370	K130414	000
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00763000240394	K130414	000
00763000240400	K130414	000
00763000240417	K130414	000
00763000240424	K130414	000
00763000240431	K130414	000
00763000240448	K130414	000
00763000240455	K130414	000
00763000115272	K130414	000